New Resources to Enhance Commercial Success in Digital Health Technology Sector
New Resources to Enhance Commercial Success in Digital Health Technology Sector
The Digital Medicine Society (DiMe), in collaboration with Peterson Health Technology Institute (PHTI) and ZS Associates, has unveiled a comprehensive suite of resources aimed at facilitating digital health technologies (DHTs) in their journey toward commercial success. Released on March 18, 2025, these tools are designed to navigate the complexities of Integrated Evidence Plans (IEPs) and equip developers to generate relevant evidence for diverse decision-makers across the health ecosystem.
Understanding Integrated Evidence Plans
As regulatory landscapes shift, the need for a proactive, evidence-driven approach to innovation has never been more crucial. The IEP toolkit offers a structured and transparent methodology, enabling innovators to comprehend evidentiary requirements, streamline market access, mitigate risks, and foster commercial success.
Past assessments highlighted significant gaps in the understanding of evidentiary needs, especially after gaining FDA authorization. Many DHTs encounter adoption hurdles due to a lack of clarity regarding evidence requirements. “Without addressing the needs of downstream stakeholders, such as payers, providers, and health systems, commercial success remains elusive,” remarked Smit Patel, Program Director at DiMe.
Key Components of the New Resources
The freshly introduced toolkit includes essential features:
- - IEP Toolkit: A detailed roadmap that outlines best practices, templates, checklists, and case examples for constructing effective evidence plans.
- - Stakeholder Map: This tool identifies key decision-makers influencing the adoption of DHTs and elaborates on their specific requirements, facilitating aligned efforts throughout the product lifecycle.
- - High-Quality Evidence Checklist: A comprehensive checklist to ensure DHT developers generate top-notch evidence that satisfies the evidential demands of downstream decision-makers.
Collaborative Effort to Foster Innovation
DiMe’s initiative is built upon its earlier successes, such as the U.S. Digital Health Regulatory Pathways and the Evidence DEFINED framework. The aim is clear: advance the use of IEPs for the development of DHTs, streamlining the pathway to widespread adoption and market success.
Maurice Solomon, Principal at ZS, emphasized the importance of this collaboration, highlighting that the resources equip companies of all sizes to approach evidence development holistically. “This work serves as a blueprint to navigate the often challenging landscape of evidence generation, ultimately aiding in the scale-up of digital health tools in clinical settings.”
Looking Ahead
DiMe remains at the forefront of several crucial initiatives aimed at leveraging digital measures to enhance patient outcomes through the effective use of digital technologies. Current efforts include a focus on continuous glucose monitoring for improving market access to effective diabetes therapies and defining benchmarks for common mental health disorders. The ultimate goal is the utilization of objective, scalable endpoints that can assess treatment outcomes more effectively.
The launch of these resources positions DiMe as a pivotal player in the digital health ecosystem, promising a positive trajectory for DHTs navigating the intricate landscape of healthcare innovation. By addressing evidentiary needs and aligning stakeholder interests, DiMe is not just advancing technology but also enhancing the likelihood of improved health outcomes for patients worldwide.
Topics Health）
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